Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 7:48 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT02366403
Description: Study staff conducted safety evaluations and followed safety protocols whenever a participant endorsed any suicidal or homicidal ideation, including via self report measures.
Frequency Threshold: 0
Time Frame: baseline to one year posttreatment (i.e. 58 weeks)
Study: NCT02366403
Study Brief: Breathing Meditation Intervention for Post Traumatic Stress Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sudarshan Kriya Yoga a standardized meditation program SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment. 0 None 0 41 0 41 View
CPT-C CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques. CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques. 0 None 1 44 1 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Admission to inpatient psychiatry NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Distressed and lost to follow up SYSTEMATIC_ASSESSMENT Psychiatric disorders None View